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Development of clear and effective discrete-choice experiment surveys is an important step toward ensuring accurate and usable preference results. Pretest interviews and pilot testing are common in the development of discrete-choice experiments, and it is important for researchers to report details of survey changes resulting from patient feedback elicited in pilot work. This paper details pilot testing of an online discrete-choice experiment to elicit preferences for long-acting antiretroviral therapies among patients with HIV.The survey included an introduction to hypothetical treatment options, descriptions of attributes, comprehension questions, instructions for completing a discrete-choice experiment, a discrete-choice experiment with 17 choice tasks, and questions about personal characteristics. We piloted the survey with 50 respondents over ten waves. Each wave incorporated design improvements based on observations made during the previous wave. Respondents completed the online survey while screen sharing with a researcher, allowing interactive discussion. We developed a scheme for assessing and categorizing the survey changes.Changes to the pilot were categorized by ways they impacted aspects of the discrete-choice experiment or the likely quality of resulting data. The four categories of impact are: understanding of attributes, underlying discrete-choice experiment and understanding of the choice question, collection of individual characteristics hypothesized to affect preference, and changes that improved clarity and usability of the survey without directly affecting the other categories (e.g., survey navigation and instructional clarity, formatting changes).Detailed attention to the respondent experience in this large pilot allowed survey improvements that will likely reduce ambiguity, ensure more accurate capture of patient preferences and, ultimately, improve product development for long-acting antiretroviral therapies.

To rank the US payers' preferences for attributes of real-world evidence (RWE) studies in the context of chronic disease and to quantify trade-offs among them.We conducted a discrete choice experiment in which 180 employees from payer organizations were tasked to choose between 2 RWE studies assuming they were assessing evidence to inform formulary decisions for chronic disease treatment. Each RWE study was characterized by 7 attributes with 3 levels each: very informative, moderately informative, and not measured. We used a D-optimal main-effects design. Survey data were fitted to a conditional logit model to obtain a relative measure of the ranking of importance for each attribute.Clinical outcomes were the most preferred attribute. It was 4.68 times as important as productivity outcomes-the least preferred attribute. It was followed by health-related quality of life (2.78), methodologic rigor (2.09), resource utilization (1.71), and external validity (1.56).This study provides a quantification of the value payers place on key RWE attributes. Across attributes, payers have higher preferences for clinical and health-related quality of life outcomes than the other attributes. Between attributes' levels, payers prefer high levels of information in clinical outcomes and methodologic rigor but are indifferent in other attributes. Our results bridge the gap between the information that payers seek and the attributes that RWE studies prioritize and effectively guide future research design.

BACKGROUND: One’s experience with dementia may affect their perceptions about dementia preventability, which in turn could influence preventive health behaviors. We aimed to examine how having a family history of dementia and caregiving experience are associated with perceptions about and self-efficacy for dementia preventability. METHODS: Cross-sectional, self-administered survey. Participants reported whether they have had a family member with dementia and, among those who reported having a family member with dementia, whether they served as a caregiver. Outcomes were perceptions about the likelihood of dementia preventability, self-efficacy for dementia prevention, and benefits of specific dementia prevention strategies. Associations were assessed via partial proportional odds model for ordinal outcome variables and logistic regression for binary outcome variables. RESULTS: Of 1,575 respondents, 71% had a family member with dementia, of which 42% served as a caregiver. People with a family member with dementia were less likely to believe that dementia is preventable (aOR = 0.75, 95% CI: 0.58, 0.96) and had lower self-efficacy for dementia prevention (aOR = 0.71, 95% CI: 0.56, 0.90). The subgroup analysis among those with caregiving experience was consistent with the primary findings, showing less belief in the likelihood of dementia preventability (aOR = 0.69, 95% CI: 0.46, 1.03) and self-efficacy (aOR = 0.75, 95% CI: 0.56, 1.00). CONCLUSION: Having a family member with dementia is associated with unfavorable perceptions about dementia preventability. Incorporating family history of dementia into communication efforts about dementia risk reduction may help address potential barriers to preventive health behaviors.

OBJECTIVE To assess the geographic variations in triptan and opioid prescribing patterns for patients with migraine. BACKGROUND Numerous guidelines recommend triptans as the standard of care for migraine attacks, yet opioids are still widely used for migraine treatment. Variation in the use of opioids and triptans for the treatment of migraine by geographic location is not well known. METHODS Using a US claims database, we conducted a retrospective cohort study of adults diagnosed with migraine between 2016 and 2018. We used a 12-month follow-up period to assess triptan and opioid utilization, stratified by the nine Census Bureau-designated divisions. To examine the geographic factors that affect triptan and opioid use among patients, we conducted two sets of multivariable analyses. First, we analyzed the odds of a patient being a triptan or opioid user in the follow-up period, defined as ≥1 triptan or opioid claim. We then analyzed the medication use rate among triptan or opioid users. RESULTS Overall, we had a final study population of 113,921 patients. In the follow-up period, 52.9% (60,247/113,921) [range: 48.0%-56.3%] of patients were triptan users and 41.0% (46,708/113,921) [range: 28.9%-48.4%] of patients were opioid users with significant differences across census divisions (p

Weight loss is an effective strategy for the management of hypertension, and bariatric surgery is the most effective weight loss and maintenance strategy for obesity. The importance of bariatric surgery in the long-term management of hypertension and which operation is most effective is less clear. We compared the effectiveness of vertical sleeve gastrectomy (VSG) and Roux-en-Y gastric bypass (RYGB) for remission and relapse of hypertension after surgery in the ENGAGE CVD cohort study (Effectiveness of Gastric Bypass Versus Gastric Sleeve for Cardiovascular Disease). Operations were done by 23 surgeons across 9 surgical practices. Hypertension remission and relapse were assessed in each year of follow-up beginning 30 days and up to 5 years postsurgery. We used a local instrumental variable approach to account for selection bias in the choice of VSG or RYGB. The study population included 4964 patients with hypertension at the time of surgery (n=3186 VSG and n=1778 RYGB). At 1 year, 27% of patients with RYGB and 28% of patients with VSG achieved remission. After 5 years, without accounting for relapse, 42% of RYGB and 43% of VSG patients had experienced hypertension remission. After accounting for relapse, only 17% of RYGB and 18% of VSG patients remained in remission 5 years after surgery. There were no statistically significant differences between VSG and RYGB for hypertension remission, relapse, or mean systolic and diastolic blood pressure at any time during follow-up.

As we reset post pandemic, providers and payers are in an excellent position to prioritize a reallocation of health care expenditures driven primarily by individual and population health gains.

Background: Higher glucose levels are associated with dementia risk in people with and without diabetes. However, little is known about how this association might vary by hypertension status and antihypertensive treatment. Most studies on modifiable dementia risk factors consider each factor in isolation. Objective: To test the hypothesis that hypertension and antihypertensive treatments may modify associations between glucose levels and dementia. Methods: Analyses of data generated from a research study and clinical care of participants from a prospective cohort of dementia-free older adults, including glucose measures, diabetes and antihypertensive treatments, and blood pressure data. We defined groups based on blood pressure (hypertensive versus not, ≥140/90 mmHg versus

ObjectiveTo assess whether angiotensin II–stimulating antihypertensives (thiazides, dihydropyridine calcium channel blockers, and angiotensin I receptor blockers) convey a lower risk of incident dementia compared to angiotensin II–inhibiting antihypertensives (angiotensin-converting enzyme inhibitors, β-blockers, and nondihydropyridine calcium channel blockers), in accordance with the “angiotensin hypothesis.”MethodsWe performed Cox regression analyses of incident dementia (or mortality as competing risk) during 6–8 years of follow-up in a population sample of 1,909 community-dwelling individuals (54% women) without dementia, aged 70–78 (mean 74.5 ± 2.5) years.ResultsAfter a median of 6.7 years of follow-up, dementia status was available for 1,870 (98%) and mortality for 1,904 (>99%) participants. Dementia incidence was 5.6% (27/480) in angiotensin II–stimulating, 8.2% (59/721) in angiotensin II–inhibiting, and 6.9% (46/669) in both antihypertensive type users. Adjusted for dementia risk factors including blood pressure and medical history, angiotensin II–stimulating antihypertensive users had a 45% lower incident dementia rate (hazard ratio [HR], 0.55; 95% CI, 0.34–0.89) without excess mortality (HR, 0.86; 95% CI, 0.64–1.16), and individuals using both types had a nonsignificant 20% lower dementia rate (HR, 0.80; 95% CI,0.53–1.20) without excess mortality (HR, 0.97; 95% CI, 0.76–1.24), compared to angiotensin II–inhibiting antihypertensive users. Results were consistent for subgroups based on diabetes and stroke history, but may be specific for individuals without a history of cardiovascular disease.ConclusionsUsers of angiotensin II–stimulating antihypertensives had lower dementia rates compared to angiotensin II–inhibiting antihypertensive users, supporting the angiotensin hypothesis. Confounding by indication must be examined further, although subanalyses suggest this did not influence results. If replicated, dementia prevention could become a compelling indication for older individuals receiving antihypertensive treatment.

This study examined the effects of a digital diabetes prevention program (DPP) on health care costs and utilization among Medicare Advantage participants. Patients (n = 501) received access to a plan-sponsored, digitally-delivered DPP accessible through computer, tablet, or smartphone. Prior research demonstrated a 7.5% reduction in body weight at 12 months. A comparison group who did not participate in the DPP was constructed by matching on demographic, health plan, health status, and health care costs and utilization. The authors assessed effects on cost and utilization outcomes using difference-in-differences regressions, controlling for propensities to participate and engage in the DPP, in the 12 months prior to DPP enrollment and 24 months after. Though post-enrollment data showed trends in decreased drug spending and emergency department use, increased inpatient utilization, and no change in total nondrug costs or outpatient utilization, the findings did not reach statistical significance, potentially because of sample size. The population had low costs and utilization at baseline, which may be responsible for the lack of observed effects in the short time frame. This study demonstrates the challenges of studying the effectiveness of preventive programs in a population with low baseline costs and the importance of using a large enough sample and follow-up period, but remains an important contribution to exploring the effects of digital DPPs in a real-world sample of individuals who were eligible and willing to participate.

BACKGROUND: Comparative evidence is needed when deciding on which bariatric operation to have for long-term cardiovascular risk reduction. OBJECTIVE: The Effectiveness of Gastric Bypass vs. Gastric Sleeve for Cardiovascular Disease (ENGAGE CVD) study compared the effectiveness of vertical sleeve gastrectomy (VSG) and Roux-en-Y gastric bypass (RYGB) operations for reduction of the American College of Cardiology (ACA) and the American Heart Association (AHA) predicted 10-year atherosclerotic cardiovascular disease (ASCVD) risk 5 years after surgery. SETTING: Data for this study came from a large integrated healthcare system in the Southern California region of the U.S. This is one of the most ethnically diverse (64% non-White) bariatric populations in the literature. METHODS: The ENGAGE CVD cohort consisted of 22,095 patients who underwent VSG or RYGB from 2009 – 2016. The VSG and RYGB were compared using a local instrumental variable (LIV) approach to address observed and unobserved confounding, as well as to conduct heterogeneity of treatment effects for patients of different age groups, baseline predicted 10-year CVD risk using the ASCVD risk score, and those who had T2DM at the time of surgery. RESULTS: Patients (2,771 RYGB and 6,256 VVSG) were primarily women (80.6%), Hispanic or non-Hispanic Black (63.7%), were 46±10 years old, with a BMI of 43.40±6.5 kg/m(2). The predicted 10-year ASCVD risk at surgery was 4.1% for VSG and 5.1% for RYGB, decreasing to 2.6% for VSG and 2.8% for RYGB 1-year postoperatively. By 5 years after surgery, patients remained with relatively low risk levels (3.0% for VSG and 3.3% for RYGB) and there were no significant differences in predicted 10-year ASCVD risk between VSG and RYGB at any time. CONCLUSIONS: Predicted 10-year ASCVD risk was low in this population and remained low up to 5 years for those with diabetes, Black and Hispanic patients, and older adults. Literature reporting significant differences between VSG and RYGB in 10-year ASCVD risk may be a result of residual confounding.

Purpose Bladder antimuscarinic (BAM) drug use is associated with increased risk of Alzheimer's disease and related dementias (ADRD). It is hypothesized that BAMs with non-selective receptor binding may increase ADRD risk more than M3-selective BAMs. This study compared ADRD risk for users of non-selective and M3-selective BAMs and examines ADRD risk associated with overall BAM use. Methods Retrospective cohort study of Medicare claims for 71 688 individuals who used BAM drugs during 2007-2009 without an ADRD diagnosis. We compared ADRD incidence (2011-2016) between non-selective BAM users (fesoterodine, flavoxate, oxybutynin, tolterodine, trospium) and M3-selective BAM users (darifenacin, solifenacin). Logistic regressions compared individuals using target drugs in the same category of total standardized daily doses (TSDD) as a standardized measure of drug exposure, and adjusted for age, sex, race/ethnicity, healthcare utilization, other medication use, socioeconomic status, and comorbidities. Secondary analyses compared ADRD risk associated with different doses of BAMs overall. Results Non-selective BAM use (compared to M3-selective) was not significantly associated with ADRD incidence. Odds ratios for non-selective use were 0.97 (CI: 0.89-1.04) for 1-364 TSDD, 0.94 (CI: 0.83-1.06) for 365-729, 1.00 (CI: 0.87-1.16) for 730-1094, and 1.03 (CI: 0.88-1.20) for >1094. Higher TSDD of BAMs overall (combining both non-selective and M3-selective BAMs), when compared to 1-364 TSDD, were associated with increased ADRD incidence (OR = 1.05 (CI: 0.99-1.10) for 365-729, OR = 1.11 (CI: 1.05-1.17) for 730-1094, and OR = 1.10 (CI: 1.04-1.15) for >1094). Conclusions Non-selective and M3-selective BAM users had similar odds of ADRD incidence, and BAM use overall was significantly associated with ADRD incidence.

Background Four prescription drugs (donepezil, galantamine, memantine, and rivastigmine) are approved by the US FDA to treat symptoms of Alzheimer's disease (AD). Even modest effectiveness could potentially reduce the population-level burden of AD and related dementias (ADRD), especially for women and racial/ethnic minorities who have higher incidence of ADRD. Objective Describe the prevalence of antidementia drug use and timing of initiation relative to ADRD diagnosis among a nationally representative group of older Americans, and if there are disparities in prevalence and timing by sex and race/ethnicity. Methods Descriptive analyses and logistic regressions of Medicare claims (2008-2016) for beneficiaries who had an ADRD or dementia-related symptom diagnosis, or use of an FDA approved drug for AD. We investigate prevalence of use and timing of treatment initiation relative to ADRD diagnosis across time and beneficiary characteristics (age, sex, race/ethnicity, socioeconomic status, comorbidities). Results Among persons diagnosed with ADRD or related symptoms, 33.3% used an approved drug over the study period. Odds of use was higher among Whites than non-Whites. Among ADRD drug users, 40% initiated use within 6 months of the initial ADRD or related symptoms diagnosis, and 16% initiated prior to a diagnosis. We observed disparities by race/ethnicity: 28% of Asians, 24% of Hispanics, 16% of Blacks, and 15% of Whites initiated prior to diagnosis. Conclusions The use of antidementia drugs is relatively low and varies widely by race/ethnicity. Heterogeneity in timing of initiation and use may affect health and cost outcomes, but these effects merit further study.

Introduction Patient preferences for long-acting antiretroviral therapies (LA-ART) should inform development of regimens with optimal adherence and acceptability. We describe a systematic process used to identify attributes and levels for a discrete choice experiment (DCE) designed to elicit preferences for potential LA-ART options in the US. Methods Our approach was conducted in four stages: data collection, data reduction, removing inappropriate attributes, and optimizing wording. We started with 8 attributes defining potential LA-ART products based on existing literature and knowledge of products in development. We conducted 12 key informant interviews with experts in HIV treatment. The list of attributes, the set of plausible levels for each attribute, and restrictions on combinations of attribute levels were updated iteratively. Results Despite uncertainty about which products will become available, key informant discussions converged on 4 delivery modes (infusions and patches were not considered immediately feasible) and 6 additional attributes. Treatment effectiveness and frequency of clinical monitoring were dropped. Oral lead-in therapy was split into two attributes: pre-treatment time undetectable and pre-treatment negative reaction testing. We omitted product-specific systemic and local side effects. In addition to mode, the final set of attributes included: frequency of dosing; location of treatment; pain; pre-treatment time undetectable; pre-treatment negative reaction testing; and late-dose leeway. Conclusions A systematic process successfully captured elements that are both feasible and relevant to evaluating the acceptability of potential LA-ART alternatives to patients.

OBJECTIVE There are few studies testing the amount of weight loss necessary to achieve initial remission of type 2 diabetes mellitus (T2DM) following bariatric surgery and no published studies with use of weight loss to predict initial T2DM remission in sleeve gastrectomy (SG) patients. RESEARCH DESIGN AND METHODS With Cox proportional hazards models we examined the relationship between initial T2DM remission and percent total weight loss (%TWL) after bariatric surgery. Categories of %TWL were included in the model as time-varying covariates. RESULTS Of patients (N = 5,928), 73% were female; mean age was 49.8 ± 10.3 years and BMI 43.8 ± 6.92 kg/m2, and 57% had Roux-en-Y gastric bypass (RYGB). Over an average follow-up of 5.9 years, 71% of patients experienced initial remission of T2DM (mean time to remission 1.0 year). With 0–5% TWL used as the reference group in Cox proportional hazards models, patients were more likely to remit with each 5% increase in TWL until 20% TWL (hazard ratio range 1.97–2.92). When categories >25% TWL were examined, all patients had a likelihood of initial remission similar to that of 20–25% TWL. Patients who achieved >20% TWL were more likely to achieve initial T2DM remission than patients with 0–5% TWL, even if they were using insulin at the time of surgery. CONCLUSIONS Weight loss after bariatric surgery is strongly associated with initial T2DM remission; however, above a threshold of 20% TWL, rates of initial T2DM remission did not increase substantially. Achieving this threshold is also associated with initial remission even in patients who traditionally experience lower rates of remission, such as patients taking insulin.

ImportanceThe comparative effectiveness of the most common operations in the long-term management of dyslipidemia is not clear.ObjectiveTo compare 4-year outcomes associated with vertical sleeve gastrectomy (VSG) vs Roux-en-Y gastric bypass (RYGB) for remission and relapse of dyslipidemia.Design, Setting, and ParticipantsThis retrospective comparative effectiveness study was conducted from January 1, 2009, to December 31, 2016, with follow-up until December 31, 2018. Participants included patients with dyslipidemia at the time of surgery who underwent VSG (4142 patients) or RYGB (2853 patients). Patients were part of a large integrated health care system in Southern California. Analysis was conducted from January 1, 2018, to December 31, 2021.ExposuresRYGB and VSG.Main Outcomes and MeasuresDyslipidemia remission and relapse were assessed in each year of follow-up for as long as 4 years after surgery.ResultsA total of 8265 patients were included, with a mean (SD) age of 46 (11) years; 6591 (79.8%) were women, 3545 (42.9%) were Hispanic, 1468 (17.8%) were non-Hispanic Black, 2985 (36.1%) were non-Hispanic White, 267 (3.2%) were of other non-Hispanic race, and the mean (SD) body mass index (calculated as weight in kilograms divided by height in meters squared) was 44 (7) at the time of surgery. Dyslipidemia outcomes at 4 years were ascertained for 2168 patients (75.9%) undergoing RYGB and 3999 (73.9%) undergoing VSG. Remission was significantly higher for those who underwent RYGB (824 [38.0%]) compared with VSG (1120 [28.0%]) (difference in the probability of remission, 0.10; 95% CI, 0.01-0.19), with no differences in relapse (455 [21.0%] vs 960 [24.0%]). Without accounting for relapse, remission of dyslipidemia after 4 years was 58.9% (1279) for those who underwent RYGB and 51.9% (2079) for those who underwent VSG. Four-year differences between operations were most pronounced for patients 65 years or older (0.39; 95% CI, 0.27-0.51), those with cardiovascular disease (0.43; 95% CI, 0.24-0.62), or non-Hispanic Black patients (0.13; 95% CI, 0.01-0.25) and White patients (0.13; 95% CI, 0.03-0.22).Conclusions and RelevanceIn this large, racially and ethnically diverse cohort of patients who underwent bariatric and metabolic surgery in clinical practices, RYGB was associated with higher rates of dyslipidemia remission after 4 years compared with VSG. However, almost one-quarter of all patients experienced relapse, suggesting that patients should be monitored closely throughout their postoperative course to maximize the benefits of these operations for treatment of dyslipidemia.

Purpose Antihypertensives may have effects on the brain beyond blood pressure lowering. Ongoing clinical trials aim to evaluate the effectiveness of approved antihypertensives in preventing dementia, including patients with and without hypertension. In order for a dementia prevention strategy using antihypertensives to be effective, it is critical to understand patient concerns about this strategy in both users and non-users of antihypertensives. Thus, this study examined the association between current use of antihypertensive and having concerns about using an antihypertensive as a dementia prevention strategy, as well as sociodemographic factors associated with concerns. Patients and methods Cross-sectional, self-administered, web-based survey was conducted among 1661 patients in a large health system in January 2018. Participants reported whether they were currently taking an antihypertensive (yes/no), and what types of hypothetical concerns they have about the idea of taking an antihypertensive to prevent dementia (yes/no, for each of 7 concerns). Associations between the two variables were assessed via logistic regression, and odds ratios with 95% confidence intervals were calculated. Results Most respondents were female (77%), 51-70 years of age (64%), and white (89%), with 30% reporting current antihypertensive use. Compared to current users, non-users were more likely to report the five following concerns: side effects from the medication, hassle to take medications, lack of evidence, not wanting to use medications, and already having normal/low blood pressure. Non-users were also less likely to report having no concerns (adjusted OR = 0.3; 95% CI = 0.2-0.4) compared to current users. Younger age and lower income were associated with having more concerns. Conclusion Patients not currently using an antihypertensive are more likely to have concerns about using an antihypertensive for dementia prevention, compared to current antihypertensive users. Patient perspectives are important to consider for the implementation of dementia prevention strategies.

BACKGROUND: There is concern that increasingly common use of patient assistance programs (PAPs), out-of-pocket assistance provided by manufacturers or foundations, distorts our understanding of patient behavior and insurance design incentives. Yet the current literature on prescription drug cost sharing largely overlooks their use. PAPs prevalence and impact on drug demand and price elasticity is a major knowledge gap. OBJECTIVE: To examine the use of PAPs among patients with multiple sclerosis (MS) and the association with drug demand in a specialty pharmacy program within a regional integrated health system that facilitates their use. METHODS: We used pharmaceutical claims data from December 2017 to December 2018 linked to detailed payer information from Kaiser Permanente Washington to characterize the prevalence of PAPs for users of 7 MS specialty drug molecules. We estimated price elasticity of demand (PED) in a two-part model by using the presence of copayment assistance as a source of cost variation. The first part estimated marginal probability of a claim in a given month with a probit model, comparing PAP users and nonusers, whereas the second part estimated days supplied of a medication, given a claim was made as a measure for demand. RESULTS: Of 789 unique patients, 480 (60.7%) used PAPs in at least 1 drug claim during the 13-month time frame, and 248 patients (31.4%) used PAPs for all of their MS drug claims. When used, copay assistance covered 100% of out-of-pocket (OOP) charges for 98% of claims and reduced patient annual OOP cost by $3,493 on average. People who used PAPs had much higher OOP charges, a lower Charlson comorbidity score, and were more likely to have insurance through an exchange. The OOP costs charged to patients was higher for claims where patient assistance was used than claims where assistance was not used ($294 vs $42, P < 0.001). Total claim amount was higher for claims that used assistance ($6,169) than claims that did not ($5,503, P < 0.001). The probability of a patient having a drug claim in a given month was 1.9% higher among those using patient assistance, although this finding was not significant (P = 0.258). An average change in price of -$168.21 with PAP use led to an average change in demand of -0.05 days, for an overall price elasticity of demand (SD = 0.028, P = 0.852) given PAP use of 0.005, indicating that the presence of PAPs did not significantly affect demand. PED estimates were not statistically significant by drug, and the exclusion of Medicare patients did not change this interpretation. CONCLUSIONS: In a mid-size integrated health system in the state of Washington, a program that promotes adherence to specialty drugs via facilitated PAP use was found to reduce patient OOP costs but had no effect on prescription drug utilization. Payers may consider embracing PAPs to remove patient financial barriers to necessary medications and use tools other than cost sharing to influence patient consumption of specialty drugs. DISCLOSURES: This manuscript was funded in part through a Pre-Doctoral Fellowship in Health Outcomes from the PhRMA Foundation awarded to Brouwer for the completion of her dissertation work. Yeung receives some salary support from Kaiser Permanente. The other authors have nothing to disclose.

Background: Medication management requires complex cognitive functioning, and therefore, difficulty taking medications might be an early sign of cognitive impairment and could be a risk factor for Alzheimer’s disease and related dementias (ADRD). Accordingly, people with difficulty taking medications may benefit from more detailed cognitive screening, potentially aiding in the diagnosis of ADRD, which is underdiagnosed. We are unaware of evidence on medication management difficulties that precede a real-world ADRD diagnosis in the USA. Objective: Examine the association between difficulty taking medications and subsequent real-world ADRD diagnoses. Design: Case-control study, using Health and Retirement Study (HRS) survey data linked to Medicare claims. Participants: A total of 1461 HRS respondents with an ADRD diagnosis observed from 1993 to 2012 (cases), matched by year of birth, wave of HRS entry, and sex to 3771 controls with no ADRD diagnosis. Main Measures: We examined the association between diagnosis of ADRD and self-reported difficulty taking medications in the preceding years (1–2 and 3–4 years prior to case definition). Control individuals were assigned the index date from their matched case. Conditional logistic regressions adjusted for age, sex, race, education, and comorbidities. Key Results: Compared with matched controls, cases had higher prevalence of difficulty taking medications 1–2 years prior to diagnosis (11.0% versus 2.3%), and 3–4 years prior to diagnosis (5.8% versus 2.3%). Adjusted analyses showed that compared with individuals without ADRD, those with an ADRD diagnosis had more than four times higher odds of difficulty taking medications 1–2 years prior (OR = 4.56 (CI 3.30–6.31)), and more than two times higher odds of difficulty taking medications 3–4 years prior (OR = 2.41 (CI 1.61–3.59)). Conclusions: Odds of medication difficulty 1–2 years prior were more than four times greater for individuals with ADRD diagnoses compared with those without ADRD. Medication management difficulties may prompt further cognitive screening, potentially aiding in earlier recognition of ADRD. Refereed/Peer-reviewed

INTRODUCTION: Most older Americans use drug therapies for chronic conditions. Several are associated with Alzheimer’s disease and related dementias (ADRD) risk. METHODS: A scoping review was used to identify drug classes associated with increasing or decreasing ADRD risk. We analyzed size, type, and findings of the evidence. RESULTS: We identified 29 drug classes across 11 therapeutic areas, and 404 human studies. Most common were studies on drugs for hypertension (93) or hyperlipidemia (81). Fewer than five studies were identified for several anti-diabetic and anti-inflammatory drugs. Evidence was observational only for beta blockers, proton pump inhibitors (PPIs), benzodiazepines (BZDs), disease-modifying anti-rheumatic drugs (DMARDs). For 13 drug classes, 50% or more of the studies reported consistent direction of effect on ADRD risk. DISCUSSION: Future research targeting drug classes with limited/non-robust evidence, examining sex, racial heterogeneity, and separating classes by molecule will facilitate understanding of associated risk, and inform clinical and policy efforts to alleviate the growing impact of ADRD.

Informants’ reports can be useful in screening patients for future risk of dementia. We aimed to determine whether informant-reported sleep disturbance is associated with incident dementia, whether this association varies by baseline cognitive level and whether the severity of informant-reported sleep disturbance is associated with incident dementia among those with sleep disturbance. A longitudinal retrospective cohort study was conducted using the uniform data set collected by the National Alzheimer’s Coordinating Center. Older adults without dementia at baseline living with informants were included in analysis. Cox proportional hazards models showed that participants with an informant-reported sleep disturbance were more likely to develop dementia, although this association may be specific for older adults with normal cognition. In addition, older adults with more severe sleep disturbance had a higher risk of incident dementia than those with mild sleep disturbance. Informant-reported information on sleep quality may be useful for prompting cognitive screening.

BackgroundOnce-daily extended-released memantine with donepezil (hereafter memantine/donepezil) may improve medication adherence but has a 60-fold higher cost compared with combined generic components. Little is known about factors associated with prescribing memantine/donepezil. We examined the association between pharmaceutical industry payments to physicians and prescribing memantine/donepezil in Medicare.MethodsA cross-sectional study was conducted. Using 2015–2016 Centers for Medicare and Medicaid Services Open Payments and Part D prescription databases, we identified unique physicians who prescribed ≥11 memantine/donepezil prescriptions from 2015 to 2016. Outcome variable was the number of memantine/donepezil prescriptions written per physician per year. The key independent variable was physician receipt of industry payments defined in 2 models: (1) number of payments and (2) amount of payment ($100 units) for memantine/donepezil received per physician per year. Multivariable Poisson regression was used, adjusting for potential confounders.ResultsAmong 4,895 unique eligible physicians in 2015–2016, the median number of memantine/donepezil prescriptions per physician per year was 19.5 (25th percentile 13, 75th percentile 32). Physicians received between 0 and 75 payments per year (median 1, 25th percentile 0, 75th percentile 2.5) for memantine/donepezil, totaling an average of $92 per year (median $10.5, 25th percentile $0, 75th percentile $33.20). Every 1 additional payment received was associated with a 2% increase in new memantine/donepezil prescriptions prescribed per physician per year (rate ratio [RR] 1.02, 95% confidence interval [CI] 1.02–1.02). Every $100 increase in payment for memantine/donepezil was associated with a 0.3% increase in new memantine/donepezil prescriptions prescribed per physician per pear (RR 1.003, 95% CI 1.002–1.004).ConclusionsReceipt of industry payments for memantine/donepezil was independently associated with increased likelihood of physician prescribing memantine/donepezil in Medicare.

BackgroundHyperlipidemia and hypertension are modifiable risk factors for Alzheimer's disease and related dementias (ADRD). Approximately 25% of adults over age 65 use both antihypertensives (AHTs) and statins for these conditions. While a growing body of evidence found statins and AHTs are independently associated with lower ADRD risk, no evidence exists on simultaneous use for different drug class combinations and ADRD risk. Our primary objective was to compare ADRD risk associated with concurrent use of different combinations of statins and antihypertensives.MethodsIn a retrospective cohort study (2007-2014), we analyzed 694,672 Medicare beneficiaries in the United States (2,017,786 person-years) who concurrently used both statins and AHTs. Using logistic regression adjusting for age, socioeconomic status and comorbidities, we quantified incident ADRD diagnosis associated with concurrent use of different statin molecules (atorvastatin, pravastatin, rosuvastatin, and simvastatin) and AHT drug classes (two renin-angiotensin system (RAS)-acting AHTs, angiotensin converting enzyme inhibitors (ACEIs) or angiotensin-II receptor blockers (ARBs), vs non-RAS-acting AHTs).FindingsPravastatin or rosuvastatin combined with RAS-acting AHTs reduce risk of ADRD relative to any statin combined with non-RAS-acting AHTs: ACEI+pravastatin odds ratio (OR) = 0.942 (CI: 0.899-0.986, p = 0.011), ACEI+rosuvastatin OR = 0.841 (CI: 0.794-0.892, pConclusionAmong older Americans, use of pravastatin and rosuvastatin to treat hyperlipidemia is less common than use of simvastatin and atorvastatin, however, in combination with RAS-acting AHTs, particularly ARBs, they may be more effective at reducing risk of ADRD. The number of Americans with ADRD may be reduced with drug treatments for vascular health that also confer effects on ADRD.

Background When compared with conventional weight loss strategies, bariatric surgery results in substantially greater durable weight loss and rates of disease remission. Objective The ENGAGE CVD (Effectiveness of Gastric Bypass versus Gastric Sleeve for Cardiovascular Disease) cohort study aimed to provide population-based, comprehensive, rigorous evidence for clinical and policy decision making regarding the choice between gastric bypass and gastric sleeve for overall cardiovascular disease (CVD) risk reduction, risk factor remission, and safety. Methods The cohort had 22,095 weight loss surgery patients from a large integrated health care system in Southern California assembled from 2009 to 2016 who were followed up through 2018. Bariatric surgery patients were followed up for the length of their membership in the health care system. Of the patients who had at least five years of follow-up (surgery between 2009 and 2013), 85.86% (13,774/16,043) could contribute to the outcome analyses for the ENGAGE CVD cohort. Results Patients in the ENGAGE CVD cohort were 44.6 (SD 11.4) years old, mostly women (17,718/22,095; 80.19%), with 18.94% (4185/22,095) non-Hispanic black and 41.80% (9235/22,095) Hispanic, and had an average BMI of 44.3 (SD 6.9) kg/m2 at the time of surgery. When compared with patients who did not contribute data to the 5-year outcome analysis for the ENGAGE CVD cohort (2269/16,043; 14.14%), patients who contributed data (13,774/16,043; 85.86%) were older (P=.002), more likely to be women (P=.02), more likely to be non-Hispanic white (P Conclusions This study had one of the largest populations of gastric sleeve patients (n=13,459). The 5-year follow-up for those patients who had surgery between 2009 and 2013 was excellent for a retrospective cohort study at 85.86% (13,774/16,043). Unlike almost any study in the literature, the majority of the ENGAGE CVD cohort was racial and ethnic minority, providing a rare opportunity to study the effects of bariatric surgery for different racial and ethnic groups, some of whom have the highest rates of severe obesity in the United States. Finally, it also used state-of-the-art statistical and econometric comparative effectiveness methods to mimic the effect of random assignment and control for sources of confounding inherent in large observational studies. International Registered Report Identifier (IRRID) RR1-10.2196/14936

Purpose Antihypertensives may have effects on the brain beyond blood pressure lowering. Ongoing clinical trials aim to evaluate the effectiveness of approved antihypertensives in preventing dementia, including patients with and without hypertension. In order for a dementia prevention strategy using antihypertensives to be effective, it is critical to understand patient concerns about this strategy in both users and non-users of antihypertensives. Thus, this study examined the association between current use of antihypertensive and having concerns about using an antihypertensive as a dementia prevention strategy, as well as sociodemographic factors associated with concerns. Patients and methods Cross-sectional, self-administered, web-based survey was conducted among 1661 patients in a large health system in January 2018. Participants reported whether they were currently taking an antihypertensive (yes/no), and what types of hypothetical concerns they have about the idea of taking an antihypertensive to prevent dementia (yes/no, for each of 7 concerns). Associations between the two variables were assessed via logistic regression, and odds ratios with 95% confidence intervals were calculated. Results Most respondents were female (77%), 51–70 years of age (64%), and white (89%), with 30% reporting current antihypertensive use. Compared to current users, non-users were more likely to report the five following concerns: side effects from the medication, hassle to take medications, lack of evidence, not wanting to use medications, and already having normal/low blood pressure. Non-users were also less likely to report having no concerns (adjusted OR = 0.3; 95% CI = 0.2–0.4) compared to current users. Younger age and lower income were associated with having more concerns. Conclusion Patients not currently using an antihypertensive are more likely to have concerns about using an antihypertensive for dementia prevention, compared to current antihypertensive users. Patient perspectives are important to consider for the implementation of dementia prevention strategies.

Introduction There is insufficient understanding of diagnosis of etiologic dementia subtypes and contact with specialized dementia care among older Americans. Methods We quantified dementia diagnoses and subsequent health care over five years by etiologic subtype and physician specialty among Medicare beneficiaries with incident dementia diagnosis in 2008/09 (226,604 persons/714,015 person-years). Results Eighty-five percent of people were diagnosed by a nondementia specialist physician. Use of dementia specialists within one year (22%) and five years (36%) of diagnosis was low. "Unspecified" dementia diagnosis was common, higher among those diagnosed by nondementia specialists (33.2%) than dementia specialists (21.6%). Half of diagnoses were Alzheimer's disease. Discussion Ascertainment of etiologic dementia subtype may inform hereditary risk and facilitate financial and care planning. Use of dementia specialty care was low, particularly for Hispanics and Asians, and associated with more detection of etiological subtype. Dementia-related professional development for nonspecialists is urgent given their central role in dementia diagnosis and care.

Highlights • Respondents were unaware of benefits/harms of pharmaceuticals for brain health. • Fish oil and vitamin E were most commonly thought to improve brain health. • Nearly one-third thought over-the-counter sleep aids were harmful to brain health., The role of medications and supplements for brain health is a fast-changing and growing field, making it difficult for patients to receive updated and accurate information. The objective of this study was to assess patients’ beliefs about the helpfulness or harmfulness of various medications and supplements on brain health. A convenience sample of adults from an integrated healthcare system completed a web-based survey. Descriptive statistics were used for this hypothesis-generating study. A total of 1661 respondents completed the survey. The majority of respondents were female (77%), between the ages of 51–70 (64%), and white (89%). Across the selected medications and supplements purported to improve a person’s brain health (vitamin E, ginkgo biloba, hormones such as estrogen or testosterone, fish oil, and statins), 46–64% of respondents reported not knowing or skipped the item regarding their helpfulness to improve brain health. One out of four respondents reported benefits of vitamin E and nearly half reported benefits of fish oil on brain health; neither benefit is supported by current evidence. For the two medication classes evaluated for increasing dementia risk (proton pump inhibitors and anticholinergics used as sleep aids), 63–77% of respondents reported not knowing or skipped the item regarding their harmfulness to brain health. Survey respondents largely reported not knowing the potential benefits and harms of different medications and supplements for brain health. Improved health communication on pharmaceutical effects on dementia risk is greatly needed, and its development and dissemination should involve healthcare providers, patients, and media outlets.

Substituting generic for brand name drugs whenever possible has been proposed to control prescription drug expenditure growth in the United States. This work investigates two types of state laws that regulate the procedures under which pharmacists substitute bioequivalent generic versions of brand name drugs. Mandatory substitution laws require pharmacists to use the generic as a default, and presumed consent laws allow them to assume that the patient agrees to the substitution. Both situations can be overruled by the patient. Using plausibly exogenous changes in states’ laws, we use difference-in-differences and a discrete choice model to show that while the mandatory switching laws have little effect, the presumed consent laws reduce consumers’ probability of purchasing brand name drugs by 3.2 percentage points. The differential effectiveness of the laws is likely caused by pharmacists’ profit motives. These results offer important implications for policies that seek to reduce drug expenditures by incentivizing the use of generic drugs.

This study evaluated the impact of a virtual version of the Diabetes Prevention Program (DPP) on healthcare utilization and costs in a Medicare Advantage population. The program was offered during 2015 to a random sample of 9,497 individuals who had metabolic syndrome or prediabetes. Program enrollees (n=501) received a 12-month virtual DPP including a wireless scale, pedometer, nutrition tracker, educational lessons, health coaching, and peer group support through an online platform. Participants with available administrative claims data during the 12 months before and 24 months following program start (n=495, mean age=69 years; 64% female; 85% white) were propensity-score matched on demographic, behavioral, and clinical factors in a ratio of 1:1 to a comparison group (n=495, selected from 6,490; mean age=69 years; 58% female; 87% white) who did not receive the DPP. In the 24 months following DPP enrollment, participants averaged 0.2 inpatient admissions, 0.3 emergency department visits, and 12.2 physician visits, compared to 0.2, 0.4, and 12.0 for controls. While the utilization values do not show a large change, a difference-in-differences regression analysis of total medical and pharmacy cost for 24 months following program start showed cost savings. The adjusted difference-in-differences effect on average cumulative cost difference was $1,110 per participant, or $46.25/month. Medical and pharmacy costs were consistently lower for participants in the post-program year. Pharmacy savings were statistically significant during the last 6 months, with a 24-month cumulative adjusted savings of $408. These cost estimates do not include the cost of the program. Results suggest that a virtual DPP can change the pattern of utilization and reduce costs in a Medicare population. Disclosure V. Chiguluri: None. D. Barthold: None. R. Gumpina: None. C. Castro Sweet: Employee; Self; Omada Health, Inc.. J. Pieratt: None. T.A. Cordier: Employee; Self; Humana Inc.. Stock/Shareholder; Self; Humana Inc.. R. Matanich: None. A. Renda: None. T.G. Prewitt: None.

Since 2011, we’ve worked to create a dialogue between Canada’s journalists and academic health policy experts to enrich the quality and quantity of health policy stories in the Canadian media. We work with a Media Advisory Board made up of journalists and professors of journalism from across the country who let us know what their needs, constraints and objectives are from a journalistic perspective. We also have a network of more than 80 health policy academics who are ready and available to be interviewed by the media and provide a non-partisan, evidence-based perspective from their areas of expertise.Working together, we have created a number of tools for enabling media coverage of health policy issues in Canada, including the preparation of media backgrounders, infographics, posters, podcasts and videos that highlight the evidence, and we conduct webinars, seminars and conferences by and for both journalists and academics alike.But our most successful initiative thus far has been having our academic experts authorOp-Ed articles on health policy issues — highlighting the evidence; they work with a professional editor to follow specific media guidelines, and then we publish the commentaries in the biggest media outlets across the country. The table below illustrates how successful this strategy has been and how receptive media outlets have been to these stories — increasingly so.This book is a selection of Op-Eds we’ve published in media outlets across the country (in both French and English) from October 2013 to October 2014. It thus provides a snapshot of Canadian health policy in the news. It is the third volume in our series (see also Canadian Health Policy in the News (2013) Making Evidence Matter in Canadian Health Policy (2014)) — all made available for free so that they may be read and used widely in educational settings.Topics are organized by chapter headings that address issues such as our challenges with providing Mental Health care; new models for Pharmaceutical Policy and commentaries that flag the myths and truths about our Aging Population and how it will impact health services. Health Care Costs and Spending are always a concern and are raised by many of the essays here including the costs of health human resources and technology. Many of our academics address the ways in which Health is More than Health Care including such issues as poverty, housing and education, while others caution that More Care is Not Always Better. Still other commentaries highlight the dangers and opportunities with Private, For-Profit Solutions to health care funding and delivery, and others compare Canadian and American Health Systems.Collected together, we hope these Op-Eds engage and enrich the dialogue and debate on a health care system that’s so important to Canadians. As we head into a federal election year in 2015, it seems certain that many of these issues will come to the fore, and it serves our democratic system that they be aired and discussed with evidence as the foundation. With journalists and academics in partnership to communicate health policy in the news, we can help navigate the evidence together.

Substituting generic for brand drugs whenever possible has been proposed as an effective way to control prescription drug expenditure growth in the United States. This work investigates whether mandatory switching and presumed consent laws are effective in increasing generic drug use. The analysis uses plausibly exogenous changes in states' drug substitution policies for identification. The Difference-in-Difference regression results indicate that mandatory switching laws have little effect. However, presumed consent laws, whereby the pharmacists could assume patients' consent to switch to generic drugs, reduce consumers' probability of purchasing brand drugs by 4.1 percentage points. We construct and estimate a bounded rationality model to explain why presumed consent laws work. In the model, consumers in states with presumed consent laws incur a cost when asking pharmacists for brand drugs. We find that presumed consent laws' effect in decreasing brand drug use is equivalent to increasing the brand drug price by 3 dollars. The average marginal effect of the policy is to reduce the probability of purchasing brand drugs by 6 and 11 percent. A welfare calculation indicates that consumers' surplus loss exceeds the insurances' gain by 7.5 dollars per person per purchase when states switch from explicit to presumed consent laws.

This study assesses the impact of reductions in cost sharing for prescription drugs on preventable hospitalizations and outpatient care utilization among the elderly in the United States. In addition to affecting demand for drugs, drug cost sharing can also affect the demand for complement services, such as primary or preventive care. In order to evaluate this possibility, I analyze the effects of varying patient cost sharing for prescription drugs on hospitalizations from ambulatory care sensitive conditions (ACSC), which can represent a failure of preventive and outpatient care. To address endogeneity from selection and sorting of individuals into insurance plans, I aggregate data from the 2000-2009 Medical Expenditure Panel Survey (MEPS) to the region-year level, and use an instrumental variables strategy. The analysis exploits exogenous variation in prescription drug cost sharing that occurred as a result of the Medicare Modernization Act of 2003, and therefore plausibly identifies causal effects of cost sharing. Results show that for the elderly in the United States, who have generous insurance coverage for other outpatient services, reductions in prescription drug cost sharing do not have an effect on hospitalizations related to ambulatory care sensitive conditions, or on specific types of preventive care utilization.

The economic burden of diabetes and the effects of the disease on the labor force are of substantial importance to policy makers. We examined the impact of diabetes on leaving the labor force across sixteen countries, using data about 66,542 participants in the Survey of Health, Ageing and Retirement in Europe; the US Health and Retirement Survey; or the English Longitudinal Study of Ageing. After matching people with diabetes to those without the disease in terms of age, sex, and years of education, we used Cox proportional hazards analyses to estimate the effect of diabetes on time of leaving the labor force. Across the sixteen countries, people diagnosed with diabetes had a 30 percent increase in the rate of labor-force exit, compared to people without the disease. The costs associated with earlier labor-force exit are likely to be substantial. These findings further support the value of greater public- and private-sector investment in preventing and managing diabetes.

Objectives. We examined the efficiency of country-specific health care spending in improving life expectancies for men and women. Methods. We estimated efficiencies of health care spending for 27 Organisation for Economic Co-operation and Development (OECD) countries during the period 1991 to 2007 using multivariable regression models, including country fixed-effects and controlling for time-varying levels of national social expenditures, economic development, and health behaviors. Results. Findings indicated robust differences in health-spending efficiency. A 1% annual increase in health expenditures was associated with percent changes in life expectancy ranging from 0.020 in the United States (95% confidence interval [CI] = 0.008, 0.032) to 0.121 in Germany (95% CI = 0.099, 0.143). Health-spending increases were associated with greater life expectancy improvements for men than for women in nearly every OECD country. Conclusions. This is the first study to our knowledge to estimate the effect of country-specific health expenditures on life expectancies of men and women. Future work understanding the determinants of these differences has the potential to improve the overall efficiency and equity of national health systems.